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Perioperative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis (PEPCORLI)

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ClinicalTrials.gov Identifier: NCT02912052
Recruitment Status : Not yet recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
A prospective Randomized Clinical Trial to investigate the Effect ofPeri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Peri-operative chemotherapy Drug: postoperative chemotherapy Phase 3

Detailed Description:

Colon cancer (colorectal cancer CRC) is one of the most common malignant tumor of digestive tract, has become the global incidence of third malignant tumors, including colorectal cancer proportion increased year by year. With the way of life of residents in our country, the adjustment of diet and aging progress, the incidence of colorectal cancer is rising the trend, and most patients have been found in advanced disease. Tumor metastasis is an important factor affecting the prognosis of colon cancer, liver metastasis, especially, including simultaneous liver metastases and delayed liver metastasis from colon cancer, about 20% to 34% will appear at the same time of liver metastasis, about 40-50% of CRC patients died of liver metastasis at present, multi disciplinary team treatment to surgical treatment of the absolute dominance of the more and more attention, and benefit, but the optimum sequence of chemotherapy and surgery, is still unclear. The preoperative chemotherapy Potential advantages include: early treatment of micrometastasis; assessment of tumor response to chemotherapy (with prognostic value, contribute to the development of postoperative treatment plan); for those patients with early progression can avoid local treatment. Preoperative treatment of the potential disadvantages include: missed the surgery opportunity window period ", probably because in early stage of tumor progress, may also be because chemotherapy achieved complete remission and to determine the extent of resection surgery has become extremely difficult.2015 second edition of the NNCN guidelines that resectable metastatic disease initial resectable patients may be liver resection, adjuvant chemotherapy and postoperative; another alternative treatment mode is around perioperative chemotherapy (perioperative chemotherapy and postoperative chemotherapy). Therefore, gaps in the determination of the timing of chemotherapy is still the guide, worth exploring.

I center to carry out laparoscopic resection of colon cancer has been more than ten years, the accumulated number of cases more than 1000 cases, with rich experience of colon cancer. Comprehensive treatment including surgery, oncology, Radiology, pathology, Department of radiotherapy, a number of departments, the Department of endoscopy MDT team, and won the outstanding team of Chinese Medical Doctor Association in 2016 MDT honor.

This study used a prospective randomized method, evaluation of colon cancer with simultaneous resectable liver metastatic lesions and peri chemotherapy surgery after neoadjuvant chemotherapy of two therapeutic schemes for short-term and long-term effect, is expected to summarize the prospective data to support the operation and chemotherapy


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis: a Prospective Randomized Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
Experimental: Peri-operative chemotherapy
Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.
Drug: Peri-operative chemotherapy
Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)
Other Name: XELOX

Active Comparator: postoperative chemotherapy
Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.
Drug: postoperative chemotherapy
Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)
Other Name: XELOX




Primary Outcome Measures :
  1. Disease free survival,DFS [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Other Outcome Measures:
  1. recurrence-free survival [ Time Frame: 5 years ]
  2. local recurrence rate [ Time Frame: 5 years ]
  3. length of postoperative hospital stay [ Time Frame: 30 days ]
  4. early complication rate [ Time Frame: 30 days ]
  5. operative time [ Time Frame: 1 day ]
  6. number of lymph nodes retrieved [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(1) 18-80 years old, patients with synchronous liver metastatic colorectal cancer confirmed by pathology diagnosis(2) ASA score: I-III (3) MDT evaluation: primary tumor can be cut, liver metastases can get complete resection at R0 level. The adjacent Hepatic segments have enough blood flow to be shared and retain sufficient liver function, liver residual volume is larger than or equal to 50%; general condition of the patient is good enough, without extrahepatic unresectable metastasis, and can tolerate systemic chemotherapy. (4) there are evaluating lesions according to the RESIST 1 edition: at least the single path of the lesions can be accurately measured, and the maximum diameter of the conventional techniques (traditional physical examination, CT, X, MRI) ≥20mm CT≥10mm or spiral (5) within 3 weeks before entering the group , the laboratory test index and evaluation of the disease show good bone marrow, liver and kidney function reserve: 1) bone marrow function : Hb ≥ 90 g/L, neutrophil absolute value is more than 1.5 x 109/L, the platelet count was larger than 80 x 109/L; 2) renal function: serum creatinine < 1.5 x ULN or the creatinine clearance rate≥ 50 mL/min; 3) liver function: AST and ALT ≤2.5 *ULN(if the disease is caused by tumor, AST and ALT≤5 *ULN, hemobilirubin ≤2 *ULN. (6) signed the informed consent.

Exclusion Criteria:

(1) the pathological diagnosis is not adenocarcinoma or multiform pathological types. (2)with clinical symptoms requiring emergency surgery for treatment (complete obstruction, bleeding, intestinal perforation). (3) have received chemotherapy treatment or combined with other the anti-tumor treatment. (4) with serious basic diseases: heart disease, kidney failure, severe liver dysfunction or liver failure, coagulation dysfunction or oral dose of anticoagulant drugs, a baseline proteinuria (total urine protein >1g/d). (5) any other contraindications for the use of chemotherapy treatment (6) patients with pregnancy (7)with previous or existing central nervous system metastasis. (8) there have been cerebrovascular accident or stroke in the past 12 months (9) any other drugs may affect safety or surgical operation history (10) multiple primary colon cancer patients, or suffer from other malignant tumors, or have been systematic chemotherapy (11) with neurological or psychiatric disorders affecting cognitive ability (12)patients cannot accept the treatment because of the psychological, family or social reasons(13) patients with liver metastasis get complete remission after preoperative chemotherapy(14)patients with severe postoperative complications cannot do chemotherapy within the prescribed time (15)liver metastases cannot get hameochronous and R0 standard resection.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912052


Contacts
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Contact: Yueming Sun, PHD 02568136026 jssym@vip.sina.com

Locations
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China, Jiangsu
Jiangsu province hospital
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Director: Fumin Zhang, PHD Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

Publications:

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02912052     History of Changes
Other Study ID Numbers: SYM20160908
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Perioperative Chemotherapy
Postoperative Chemotherapy
Colon Cancer
Resectable Liver Metastasis

Additional relevant MeSH terms:
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Neoplasm Metastasis
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplastic Processes
Pathologic Processes